The present invention is directed toward gastrostomy feeding appliances or devices and, more particularly, to gastrostomy devices, methods for manufacturing gastrostomy devices, and methods for securing gastrostomy devices to a patient.
Over the years, several different designs for gastrostomy feeding devices have been proposed. Each of these designs has an internal bolster, an external bolster, and a feeding conduit that extends from the external bolster toward or through the internal bolster. A valve is typically provided to prevent reflux of gastric fluid through the feeding conduit. The internal bolster prevents the feeding conduit from being withdrawn from the patient's stoma, and the external bolster provides means for connecting the feeding device with a food supply tube.
Generally, these prior art feeding device designs may be separated into two basic categories: those with fixed, non-expandable internal bolsters, and those with expandable or inflatable internal bolsters. With regard to the latter category, several problems have been encountered.
The prior art expanding bolster designs have not satisfied the conflicting requirements of such feeding devices. The inflatable bolster must be capable of selected inflation/deflation and must be inflated and deflated from an exterior of the patient's body. The exterior bolster should not protrude too far from the patient's body, both for the patient's comfort and to prevent the bolster from becoming snagged on the patient's clothes or other items. The air passageway or lumen connecting the interior balloon to the exterior, must not significantly increase the diameter or material thickness of the tubular member extending between the interior and exterior bolsters. The air passageway must not interfere with the food supply tube connecting means and must not weaken the overall device design. Finally, the internal and external bolsters must not interfere with placement or removal of the device.
Due to these competing interests, there exists a need in the art for a low profile balloon feeding or gastrostomy device which balances these conflicting requirements and which provides a readily usable and satisfactory design.